MAUDE Adverse Event Report: UNKNOWN SYNVISC ONE PFS 8MG/ML; ACID, HYALURONIC, INTRAARTICULAR

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Patient will no longer be using this medication.She stated she had it was administered and she ended up in the er (emergency room) due to blood clots at injection site.No other information provided.

• Brand Name: SYNVISC ONE PFS 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18799772
• MDR Text Key: 336565374
• Report Number: MW5152107
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468009003
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female